Fda May Approve Aids-curb Drug

January 10, 1987|By Ronald Kotulak, Science Writer.

An antiviral drug that has produced promising early results in apparently preventing people infected with the AIDS virus from developing the deadly disease could be approved for wider use within a few weeks, Dr. Frank Young, commissioner of the federal Food and Drug Administration, said Friday.

Approval depends on a careful evaluation of the entire study to verify the preliminary findings and a request by the company that makes the drug for permission to dispense it on a broader basis, Young said.

``Because AIDS is such a dreadful disease, we want to do everything we can to speed up any possible therapy for it,`` he said.

The drug, ribavirin, falls into a special FDA program designed to expedite any therapy or drug treatment for AIDS, which is now considered uniformly fatal, and for which there is no cure. More than 29,000 cases of AIDS have been diagnosed in this country and more than half of the victims have died.

The first drug to be approved under this special category is AZT, which has recently become available at certain medical centers. AZT appears to prolong the lives of victims of AIDS--acquired immune deficiency syndrome.

In an announcement made earlier in the day, Robert Finch, a former secretary of health, education and welfare and chairman of Viratek Inc., the manufacturer of ribavirin, reported that the compound appeared to prevent patients with lymphadenopathy syndrome (LAS) from developing AIDS.

These are people who have been infected with the AIDS virus and who have developed swollen lymph glands, but who have not fully developed AIDS. Many of these people eventualy progress to AIDS, which destroys a person`s immune defense system.

The clinical trials at medical facilities in New York, Houston, Miami and Los Angeles were sponsored by Viratek, a subsidiary of ICN Pharmaceuticals, with financing provided by Eastman Kodak Co.

The year-long study involved 163 patients who were diagnosed as having LAS. Of these, 52 were treated with 800 milligrams of ribavirin daily and 55 were given 600 milligrams a day. A control group of 56 patients received a placebo, a chemically inactive substance. Neither the patients nor the physicians knew which compound was being administered.

The preliminary findings showed that none of the 52 patients receiving 800 milligrams of ribavirin developed AIDS while six of the 55 receiving 600 milligrams developed the disease. Ten of the 56 patients receiving a placebo developed AIDS.

The trials were monitored by an independent safety and evaluation committee, which found that ribavirin was well tolerated and that no significant side effects were observed, a company spokesman said.

The trials were conducted at New York Hospital-Cornell University Medical Center in New York, M. D. Anderson Hospital in Houston, University of Miami, and Los Angeles County/University of Southern California Outpatient Center in Los Angeles.

Although a summary of the preliminary findings with ribavirin were given to the FDA on Monday, the company has not yet sought permission to make the drug more widely available under what is called a ``treatment investigational new drug application,`` the spokesman said.